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Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE)

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ClinicalTrials.gov Identifier: NCT04402385
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
To determine if low dose aspirin reduces the incidence of hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome) in pregnant women with stage 1 hypertension and elevated blood pressure.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Stage 1 Hypertension Elevated Blood Pressure Drug: Aspirin 81 mg Drug: Placebo Phase 2

Detailed Description:

At the baseline visit, women will go through informed consent and review of study eligibility. Objectives of the study, participation requirements, eligibility inclusion and exclusion will be reviewed in detail. If these are not met, the woman is excluded from the study. If she meets inclusion criteria, a checklist of exclusion criteria will be reviewed. If any exclusions are met, the woman is excluded from the study. The consent form will be reviewed in detail. If the woman consents and signs all pages of the form, randomization follows.

Randomization will be done in a 1:1 allocation ratio between the treatment and placebo arms, stratified by blood pressure group (elevated blood pressure and stage 1 hypertension). A computer algorithm will assign participant based on random permuted blocks design with block size between 2-4 within each strata. Each participant will have an assigned Study ID number that is linked to their random assignment.

Participants will be contacted by telephone 1 week after randomization. The purpose of this visit is to ensure the participant has received study medication and initiated the regimen.

The third encounter will be 6 weeks (+/- 1week) after randomization in person to coincide with routine prenatal visit or via telephone. The purpose of this study visit is to review their pregnancy course, use of study medications, any side effects, difficulties with the study, and have opportunities to make comments and/or ask questions. The participants will be asked to bring their study medication for pill count at the time of this encounter, if the study visit is able to be performed in person. Study participants will continue their routine prenatal care with pregnancy management performed routinely per their provider.

The fourth encounter will be 16 weeks (+/- 1week) after randomization in person to coincide with routine prenatal visit or via telephone. If the participant is already delivered by this time, the visit will be performed via telephone postpartum. The purpose of this study visit is to review their pregnancy course, use of study medications, any side effects, difficulties with the study, and have opportunities to make comments and/or ask questions. The participants will be asked to bring their study medication for pill count at the time of this encounter, if the study visit is able to be performed in person.

The rest of the study will be conducted via chart review. Each prenatal visit will be reviewed for blood pressure, evaluation of symptoms, review of any laboratory and/or imaging results. New diagnoses, medications, and hospital admissions will be documented.

Delivery records will be abstracted for outcomes listed below. Neonatal records will be reviewed from birth until 1 year of age. Neonatal and infant chart abstraction will include birthweight, Apgar scores, hospital course, problem visit, diagnoses, medications, emergency department visits, and hospitalizations. Participant's postpartum course will be reviewed for 1 year postpartum, including outpatient visits, emergency department visits, and any hospitalizations.

The study will be performed by an intent-to-treat analysis. Thus, even women who discontinue study medication will be included in final analyses.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE)
Actual Study Start Date : August 6, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
Participants randomized to 81 mg of Aspirin daily
Drug: Aspirin 81 mg
Participants randomized to 81 mg of Aspirin daily

Placebo Comparator: Placebo
Participants randomized to placebo daily
Drug: Placebo
Participants randomized to placebo daily




Primary Outcome Measures :
  1. Development of hypertensive disorder [ Time Frame: after 20 weeks gestation until 6 weeks postpartum ]
    This measure is operationally defined as a yes/no response to the development of any hypertensive disorder of pregnancy (gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome). This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.


Secondary Outcome Measures :
  1. Development of gestational hypertension [ Time Frame: after 20 weeks gestation until 6 weeks postpartum ]
    This measure is operationally defined as a yes/no response to the development of gestational hypertension. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.

  2. Development of preeclampsia [ Time Frame: after 20 weeks gestation until 6 weeks postpartum ]
    This measure is operationally defined as a yes/no response to the development of preeclampsia. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.

  3. Development of preeclampsia- 37 weeks [ Time Frame: up to 37 weeks gestation ]
    This measure is operationally defined as a yes/no response to the development of preeclampsia at less than 37 weeks of pregnancy. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.

  4. Development of preeclampsia- 34 weeks [ Time Frame: up to 34 weeks gestation ]
    This measure is operationally defined as a yes/no response to the development of preeclampsia at less than 34 weeks of pregnancy. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.

  5. Development of eclampsia [ Time Frame: after 20 weeks gestation until 6 weeks postpartum ]
    This measure is operationally defined as a yes/no response to the development of eclampsia. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.

  6. Development of HELLP syndrome [ Time Frame: after 20 weeks gestation until 6 weeks postpartum ]
    This measure is operationally defined as a yes/no response to the development of HELLP syndrome. This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.

  7. Spontaneous preterm delivery [ Time Frame: Up to 37 weeks ]
    This measure is operationally defined as a yes/no response to a spontaneous preterm delivery up to 37 weeks of pregnancy.

  8. Spontaneous preterm delivery [ Time Frame: Up to 34 weeks ]
    This measure is operationally defined as a yes/no response to a spontaneous preterm delivery up to 34 weeks of pregnancy.

  9. Fetal growth restriction [ Time Frame: after 20 weeks gestation until delivery ]
    Fetal growth restriction is estimated fetal weight <10th percentile for gestational age by Hadlock criteria with Yale New Haven Health practice-specific growth curves.

  10. Birthweight [ Time Frame: day of life 0 ]
    Birthweight small for gestational age (<10% by sex-specific World Health Organization growth charts)

  11. Neonatal ICU Admission [ Time Frame: Birth until 1 year of age ]
    Neonatal ICU admission is operationally defined as a yes/no to whether a newborn was admitted to the neonatal ICU admission.

  12. Stillbirth [ Time Frame: after 20 weeks gestation until delivery ]
    Stillbirth is operationally defined as a fetal death at or after NEED TIME.

  13. Neonatal Adverse Events [ Time Frame: Birth until 1 year of age ]
    Neonatal adverse events are operationally defined as a composite yes/no response of any of the following: need for respiratory support, necrotizing enterocolitis, neonatal sepsis, retinopathy of prematurity, intraventricular hemorrhage, neonatal death.

  14. Placental Abruption [ Time Frame: after 20 weeks gestation until delivery ]
    Placental abruption is operationally defined as a yes/no response to a placental abruption verified either clinically or as seen on pathologic placental examination.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Elevated blood pressure (At least 2 systolic BP 120-129 mm Hg within 1 year pre-pregnancy until 20 weeks gestational age on at least 2 separate healthcare encounters) or Stage 1 hypertension (At least 2 systolic BP 130-139 and/or diastolic BP 80-89 within 1 year pre-pregnancy until 20 weeks gestational age on at least 2 separate healthcare encounters)
  • Speaks English or Spanish
  • Informed and written consent
  • Confirmed single live intrauterine pregnancy (confirmed by positive cardiac motion by transvaginal or transabdominal ultrasound)

Exclusion Criteria:

  • Chronic hypertension
  • Pre-gestational diabetes
  • Chronic renal disease

    - diagnosis of stage 1 chronic kidney disease or higher and/or GFR <60 mL/min with duration at least 3 months and/or history of kidney transplantation and/or undergoing peritoneal or hemodialysis

  • Systemic lupus erythematous
  • Antiphospholipid antibody syndrome (diagnosis made by having 1 or more clinical criteria and 1 or more laboratory criteria)

    • Clinical criteria: venous thrombosis, arterial thrombosis, obstetric complications (3 or more unexplained consecutive spontaneous abortions <10 weeks gestation, 1 or more unexplained deaths of a morphologically normal fetus after 10 weeks gestation, 1 or more premature births before 34 weeks gestation attributable to placental insufficiency, including severe preeclampsia or fetal growth restriction)
    • Laboratory criteria: lupus anticoagulant, anti-cardiolipin IgG or IgM with titer >99th percentile, anti-beta 2 glycoprotein IgG or IgM with titer >99th percentile. Laboratory result must be positive twice at least 12 weeks apart
  • Multifetal gestation
  • 20 weeks gestation at time of randomization based on American College of Obstetricians and Gynecologists dating criteria. Dating will be based on last menstrual period (LMP) if regular, sure LMP is available that agrees with ultrasound dating. Otherwise, earliest ultrasound will be used for dating purposes.
  • Prior history of hypertensive disorder of pregnancy
  • Current pregnancy with known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy
  • Women with contraindications to taking aspirin (bleeding diathesis such as Von Willebrand's disease, peptic ulcer disease, aspirin hypersensitivity, nasal polyps, asthma with aspirin-induced bronchospasm, severe liver disease).
  • Concurrent participation in another study that influences risk of preeclampsia
  • Women who do not plan to deliver within the YNHH system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402385


Contacts
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Contact: Uma Reddy, MD, MPH (877) 925-3637 uma.reddy@yale.edu
Contact: Victoria Greenberg, MD (301) 580-4697 victoria.greenberg@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06512
Contact: Victoria Greenberg, MD       victoria.greenberg@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Uma Reddy, MD, MPH Yale University
Principal Investigator: Hillart Hosier, MD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04402385    
Other Study ID Numbers: 2000028023
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yale University:
Aspirin
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics